510(k) · Cleared
ClearedRectangular Multiplace Hyperbaric Chamber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gulf Coast Hyperbarics, Inc. · CBF Chamber, Hyperbaric
Cleared on May 22, 2009 as substantially equivalent to K031649 (Fink Engineering Pty, Ltd., 2003) and 2 other predicates after a 269-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- May 22, 2009
- Review
- 269 days
- Class
- Class II
- Product code
- CBF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K930748 (1993). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK930748 Sigma MP Multiplace Hyperbaric ChamberPerry Baromedical Services · 1993
- 1 generation backK031649 SL8/DL8/TL20 Hyperbaric Oxygen Treatment FacilitiesFink Engineering Pty, Ltd. · 2003
- This deviceK082455 Rectangular Multiplace Hyperbaric ChamberGulf Coast Hyperbarics, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930748 | Sigma MP Multiplace Hyperbaric Chamber | Perry Baromedical Services | 1993 | — |
| −1 | K031649 | SL8/DL8/TL20 Hyperbaric Oxygen Treatment Facilities | Fink Engineering Pty, Ltd. | 2003 | — |
| 0 (this device) | K082455 | Rectangular Multiplace Hyperbaric Chamber | Gulf Coast Hyperbarics, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CBF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CBF device
- #1 K240569 FESL FINK Chamber; FEDL FINK Chamber; FETL…score 8.7 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031649 | SL8/DL8/TL20 Hyperbaric Oxygen Treatment FacilitiesSummary page 2…n's HSWuA, FL 32444 (0)2)1-1441 Equivalent Devices: Fink Engineering Multiplace Hyperbaric Chamber- K031649 Perry Baromedical Multiplace Hyperbaric Chamber- K930748 Gulf Coast Hyperbarics Multiplace Hyperbaric Chamber - K95… | 2003 |
| * | K930748 | Sigma MP Multiplace Hyperbaric ChamberSummary page 2…(0)2)1-1441 Equivalent Devices: Fink Engineering Multiplace Hyperbaric Chamber- K031649 Perry Baromedical Multiplace Hyperbaric Chamber- K930748 Gulf Coast Hyperbarics Multiplace Hyperbaric Chamber - K950957 Device Description The Gulf Coast Hyperbarics rectangula… | 1993 |
| * | K950957 | Multiplace Hyperbaric Treatment Chamber SystemSummary page 2…ring Multiplace Hyperbaric Chamber- K031649 Perry Baromedical Multiplace Hyperbaric Chamber- K930748 Gulf Coast Hyperbarics Multiplace Hyperbaric Chamber - K950957 Device Description The Gulf Coast Hyperbarics rectangular multiplace hyperbaric chambers are designed and manufactured in acco… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K031649.
How does its category compare?
All CBF devicesCBF Chamber, Hyperbaric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · CBF
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CBF
87in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBF
2in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CBF
25in 2025
MAUDE reports naming product code CBF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 2 |
| 2008 | 3 | 134 | 2 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 3 | 87 | 0 | 11 |
| 2011 | 1 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 9 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 5 |
| 2017 | 1 | — | 0 | 9 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 0 | — | 0 | 9 |
| 2023 | 1 | — | 0 | 13 |
| 2024 | 1 | — | 0 | 13 |
| 2025 | 0 | — | 0 | 25 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
It is the expressed, intended use of the Gulf Coast Hyperbaric rectangular hyperbaric chamber to provide therapy to those patients with selected medical conditions that have been determined to respond to the application of hyperbaric oxygen. As a Class II prescriptive device, it is further intended for physician involvement in their procurement and routine use. The UHMS is the professional medical organization chartered with setting the standards of care…
Read the full statement (249 words)
It is the expressed, intended use of the Gulf Coast Hyperbaric rectangular hyperbaric chamber to provide therapy to those patients with selected medical conditions that have been determined to respond to the application of hyperbaric oxygen. As a Class II prescriptive device, it is further intended for physician involvement in their procurement and routine use.
The UHMS is the professional medical organization chartered with setting the standards of care defining the appropriate use of hyperbaric oxygen. More specifically, the UHMS publishes a listing of medical conditions that have been clearly established as appropriate primary or adjunctive use of hyperbaric oxygen (HBO). The disorders on the list have been scientifically validated and verified through extensive data collection. It should be noted that the list is dynamic. Based on the strength of the scientific data, disorders are both added and removed from the list, depending on the outcomes of scientific pursuit.
The conditions listed as appropriate for the use of HBO in the current edition of the Hyperbaric Oxygen Therapy Committee Report (1999) is as follows:
1. Air or gas embolism
2. Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
3. Clostridial myositis and myonecrosis
4. Crush injury, compartment syndrome, and other acute traumatic ischemias
5. Decompression sickness
6. Enhanced of selected problem wounds
7. Exceptional blood loss anemia
8. Necrotizing soft tissue infections
9. Osteomyelitis (refractory)
10. Delayed radiation injury (soft tissue and bony necrosis)
11. Skin grafts and flaps (compromised)
12. Thermal bums
13. Intracranial abscess
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K082455 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082455: Rectangular Multiplace Hyperbaric Chamber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082455
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026